Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012ZX09303-003 | Other Identifier | China National Major Project |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kun Ming KingBio Biotechnology Co. LTD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether Orcinoside Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in the Chinese Patients with Depression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orcinoside 25mg per day | Experimental |
| |
| Orcinoside 50mg per day | Experimental |
| |
| Orcinoside 100mg per day | Experimental |
| |
| Orcinoside 200mg per day | Experimental |
| |
| Orcinoside 400mg per day | Experimental |
| |
| Orcinoside 600mg per day | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orcinoside | Drug | oral, twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of total score from baseline in MADRS and HAMD scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| response rate and remission rate | 6 weeks | |
| decreasing rate from baseline in MADRS | 6 weeks | |
| decreasing rate from baseline in HAMD scale |
| Measure | Description | Time Frame |
|---|---|---|
| vital sign | 6 weeks | |
| AE(adverse events) | 6 weeks | |
| laboratory examination |
Inclusion Criteria:
296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD PhD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| Guangzhou Brain Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23353659 | Background | Wang ZH, Huang J, Ma XC, Li GY, Ma YP, Li N, Wang JH. Phenolic glycosides from Curculigo orchioides Gaertn. Fitoterapia. 2013 Apr;86:64-9. doi: 10.1016/j.fitote.2013.01.008. Epub 2013 Jan 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 weeks |
| change from baseline in HAMA | 6 weeks |
| CGI(CGI-S,CGI-I) | 6 weeks |
| sleep VAS scale. | 6 weeks |
| 6 weeks |
| ECG | 6 weeks |
| C-SSRS | 6 weeks |
| Guangzhou |
| Guangdong |
| 510370 |
| China |
| Hebei Province Mental Health Center | Baoding | Hebei | 071000 | China |
| Wuhan Mental Health Center | Wuhan | Hubei | 430022 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | 214151 | China |
| the first affiliated hospital of Xi'an Jiaotong University | Xi'an | Shan'xi | 710061 | China |
| Xi'an Mental Health Center | Xi'an | Shan'xi | 710061 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |